The role of the Biostatistics Core in this program is provide biostatistical expertise In study design, data analysis, and data management. The Core is staffed by three statisticians and is led by Elizabeth Garrett- Mayer, PhD. Biostatisticians from this Core have worked with investigators in all projects to optimize experimental designs, to assist with study planning including sample size justification, and perform analysis of the data resulting from experiments. Analytic plans have been developed for each project and each aim by Core biostatisticians, which includes in vitro studies, in vivo animals experiments, translational studies, and clinical trials. When appropriate novel statistical approaches are used, such as an adaptive randomization scheme for a randomized phase II study in Project 5. From the point of view of study design and data analysis methodology, numerous themes run across Projects, including hierarchical models to account for correlation of outcomes of mice transplanted with cells from the same sample. Centralization will foster bonds and communication between project leaders and statistical collaborators, facilitate matching of investigators with the most appropriate statistical collaborator, and contribute to dissemination of state-of-the art analysis techniques.